2
Alexander Elbert, PhD, PMP
Has no real or apparent conflicts of interest to report.
Shathiya Navaneeth
Has no real or apparent conflicts of interest to report.
Conflict of Interest
3
• About Cystic Fibrosis Foundation (CFF)
• About Cystic Fibrosis Foundation Patient Registry (CFFPR)
• Uses of CFFPR data
• Shifting Paradigm for CFFPR data: CFSmartReports
• Using CFSmartReports for
o Pre-visit planning
o Population management
o Clinical trial recruitment
o Co-production of care
• CFFPR and EMR data exchanges
• Summary and future steps
Agenda
4
• Describe main uses of disease-specific registry
data
• Explain how registry data provides value to
clinicians
• Demonstrate practical use of registry data in
clinical care
• Identify differences between EMR and registry
data
Learning Objectives
5
Autosomal recessive genetic disorder
• 800 - 900 new cases/year in USA
• 30 - 35,000 US patients (80 - 110,000+
worldwide)
Most common life-shortening inherited disease
of Caucasians
• Complex, multi-system chronic disease
• Majority of deaths due to lung disease
Cystic Fibrosis (CF)
6
CF Foundation History
Founded by parents of CF
patients in 1955
Cystic Fibrosis Foundation
now
Mission: To assure the
development of means to cure
and control CF and to improve
quality of life for individuals with
CF
Mission: To cure cystic fibrosis
and to provide all people with
the disease the opportunity to
lead full, productive lives by
funding research and drug
development, promoting
individualized treatment, and
ensuring access to high-quality,
specialized care.
7
CF Survival Data
Cystic Fibrosis Foundation Patient Registry, Annual Data Report 2017
8
CF Foundation Strategic Pillars
Field / fundraising /
investments
Communications
People, operations,
& technology
Accelerate
research
and drug
develop-
ment to
enable
discovery
of a cure
Define and
enable
high-
quality,
specialized
care
Engage and
enable
people with
CF to lead
full and
productive
lives
Ensure that
patients
have
access to
care
I
II
IV
III
Program areas
Enabling
functions
Research &
Tx Devt
Clinical Affairs
Access &
Advocacy
Community
Partnerships
• Investigators
• TDNs
• Patients &
families
• Care
providers
• Care centers
• Patients &
families
• Payers
• Policy-makers
• Regulators
• Patients &
families
• Patients and
families
9
CF Foundation Care Center Network
The CF Foundation sustains a network of 121 accredited CF care
centers (comprised of 121 pediatric care programs, 105 adult care
programs and 51 affiliate programs) across the United States.
10
CFF Patient Registry History
Metrics on
center
outcomes
made
public
CF Registry
started by
Dr. Warwick
Paper
questionnaires
Annual
• Demographics
• Treatments
• Exacerbations
1960
s
1980
s
Data transfer on
floppy disks
Quarterly
• Height
• Weight
• Pulmonary
Functions
• Microbiolog
y
1994
Center
Specific
Reports
1999
Separate
reports
created
for clinical
and lay
audience
s
2003
Genotypes
Web-based
platform
Encounter
based
• Height
• Weight
• Pulmonary
Functions
• Microbiolog
y
2002
Detailed
medication
collection
• Mucolytics
• Inhaled
antibiotics
• Bronchodilat
ors
• Corticosteroi
ds
2006
Annual
Reports
Produce
d
Enhanced
Web-based
platform
Encounter based
• Ability to embed
studies
• CRMS and
CFTR –related
diagnoses
added disorders
• Expanded data
collection in
microbiology,
genotypes and
infants under 2
y.
2017
Centers
started
using
registry
data via
CFSmartRe
ports in
pre-visit
planning
2010
CFF begins to
maintain Registry
under leadership of
Dr. Bob Beall
11
CFFPR Today
“The best registry in
America, in my opinion,
is the Cystic Fibrosis
registry”
Martin Adel Makary, M.D., M.P.H.
Surgical Director, Johns Hopkins Multidisciplinary Pancreas
Clinic
Professor of Surgery, Interview to National Public Radio, 2015
Inclusion criteria
• Seen at CF Care Center
• Consent to participate
Data collected at:
• Diagnosis
• Clinic visits
• Hospitalizations and Home
IV treatments
• Annually
12
• Generalizability
– Approximately 84% of individuals with CF in the US enrolled
• Lost-to-follow-up
– Retention rate for the 2009 cohort through 2013 was 90.6%
• Completeness
– 95% of encounters and 90% of hospitalizations in the medical
record captured
• Accuracy
– Registry data matched the medical record 82.6% to 99.9% of
the time depending on the data element
About CFFPR Data
13
Data for
Clinical
Trials
Data for
Phase IV
studies
Quality
Improve-
ment
Data
Researc
h
Internati-
onal
Compar-
isons
Disease
Surveilla
-nce
13
CF RegistryCF Registry
Data Research Results
- Guidelines
- Treatment
- Knowledge
Uses of the CFFPR
- Publications
14
Uses of CFFPR data: Annual Reports
Highlights Report:
4 pages
Annual Data Report:
85
-90 pages
Center Specific
Report:
182 pages
15
Uses of CFFPR data: Annual Reports
16
Uses of CFFPR data: Data Transparency
“In December 2006,
CFF succeeded in
persuading its centers
to make public their
individual results,
adjusted for the
severity of disease in
their population “
Gawande, Atul. Better. New
York: Henry Holt and
Company, 2007
17
Registry
data
collection
Data
transfer to
CFF and
cleansing
Data
processin
g
Data
reporting
CF clinic
CF RegistryCF Registry
Accelerating data availability
18
Patient-centric data
There are ~4000 patients in CFFPR whose data has been
entered by CF Centers located in at least three different States.
Images: GNU from https://icons8.com
CFFPRCFFPR
19
How CFFPR data brings value to clinicians
• History from birth to now (or to death) for majority patients
• All disease-specific information in one place
• Reports highlight missing or recommended tests/screening
• Identifying patients for clinical trials
• Quality improvement (CF Learning Network)
• Analytic capabilities
20
• About Cystic Fibrosis Foundation (CFF)
• About Cystic Fibrosis Foundation Patient Registry (CFFPR)
• Uses of CFFPR data
• Shifting Paradigm for CFFPR data: CFSmartReports
• Using CFSmartReports for
o Pre-visit planning
o Population management
o Clinical trial recruitment
o Co-production of care
• CFFPR and EMR data exchanges
• Summary and future steps
Agenda
21
Shifting Paradigm for CFFPR data
CFSmartReports – reporting application with
patient–level data
22
Pre-visit planning
Weekly
Meetin
g
Weekly
Meetin
g
Select patients
to be seen
soon
Print one or all
reports and
review data
Clinical
care
decisions
23
Pre-visit planning: care decision
examples
• Review pulmonary function and
nutrition trends
• Identify any labs required (e.g. glucose
screening)
• Analyze patient’s current and past
medications and complications
• Evaluate patient’s microbiology
infections
• Identify patients potentially eligible for
clinical trial enrollment
Weekly
Meetin
g
Weekly
Meetin
g
24
Patient Summary Report (PSR)
Home IV
treatment
Hospitalization
25
PSR: Microbiology History
Timeline of cultures
Species
26
Population Management Reports
• Pre-built customized reports to identify patient
population that can benefit from special
management (e.g. low spirometry function)
• Custom reports requested by the care teams
• Integrated with Patient Cohort Tool
27
Population Management Reports
28
Patient Cohort Tool
• Group patients based on
one or more clinical
criteria
• Over 400 data fields
from CFFPR forms
available to choose from
• Cohort fields pull
patient’s most recent
data
29
Patient cohorts used in population
management
30
Clinical Trial Recruitment
20+ active clinical trials are hosted on CFSmartReports
Study Identified
Potentially
eligible patient
list + relevant
data
Query built based on
inclusion and
exclusion criteria of
the study protocol
Daily
31
Clinical Trial Recruitment
32
0
20
40
60
80
100
120
140
9/1/2017 11/1/2017 1/1/2018 3/1/2018 5/1/2018
Number of times Rare
CFTR Mutation Cell
Collection Query (RARE)
run
Number times run
CFSmartReports contributes to enrollment in clinical trials
Clinical Trials in CFSmartReports
33
Co-production of Care
34
Co-production of care
“I want to know how many of you have HEARD of
CFSmartReports, how many of you have RECEIVED your
CFSmartReports, and how many of you (like me) have
never heard of it.”
“CFSmartReports
should be an essential
part of your clinic visit.”
Gunnar Esiason*
9/17/2018
*Gunnar has over 6,000 followers on Facebook and Twitter
35
CFSmartReports: Other functions
• Benchmarking of health outcomes
• Data verifications
• Data entry analyses
• Testing new measures
36
Pre-visit planning
Share Summary Reports
with patients
Review patients’
clinical
trial eligibility
Population management
Other
54.7%
51.4%
43.1%
22.0%
7.7 %
Based on 2018 survey of the CFF Care Center Network (n=328)
How clinicians use CFSmartReports
37
• About Cystic Fibrosis Foundation (CFF)
• About Cystic Fibrosis Foundation Patient Registry (CFFPR)
• Uses of CFFPR data
• Shifting Paradigm for CFFPR data: CFSmartReports
• Using CFSmartReports for
o Pre-visit planning
o Population management
o Clinical trial recruitment
o Co-production of care
• CFFPR and EMR data exchanges
• Summary and future steps
Agenda
38
CFFPR and EMR differences
Data area
EMR Records
CFFPR
Medications
Detailed records for each
prescribed drug
Classes of medications,
e.g. classes of antibiotics
Pulmonary
Exacerbations
N/A
Collected, one of key
concepts in CF
Complications/
Comorbidities
Could be in medical
transcription
Granular data
CFTR Genotype
Scanned lab reports
Two alleles and poly
-T
tract data for select
mutations
SES data, participation
in clinical trials, etc.
May or may not be
present
Collected for 30
-95% of
registry population
General rule: CFFPR collects only data that is relevant or might be
relevant to health outcomes of people with CF
39
CFFPR and EMR data exchanges
1. Most common EMR in the CF Care Center Network: Epic
2. Both inpatient and outpatient data are needed for CFFPR
3. Not all data elements required for CFFPR are in EMR
Pilot project launched November 2018 to evaluate feasibility of
electronic data exchanges between EMRs and CFFPR
40
CFSmartReports Usage by Program, 2017-18
100-150 CF care programs are using CFSmartReports every week
41
Patient Summary Report (PSR) Downloads,
2017-18
1000 or more PSRs are downloaded by CF Care Teams every week
42
• “Saves an incredible amount of time to not have to dig through
labs, charts, etc… joy in work!”
• Allows to use time more valuably to track down referrals and other
important info
• “Provides great historical information about each patient (we
project the report on the screen during PVP meetings and have
had some great team dialogue about care)”
• “Serves as a great data quality check – we have found some
missing data variables based on reviewing the reports together”
• “Motivates our team to be more responsive to changes in data -
e.g. respond to a small change in lung function that we may not
have responded to before”
• “Highlights which patients are not consented for PortCF and
getting them on board so they can benefit from these reports”
CFSmartReports feedback from care
teams
43
CFFPR data is helping care teams with pre-visit planning, population
management, and finding patients eligible for clinical trials. CF-specific
PSRs stimulate interest of patients and their families in co-production of
care. Use of CFSmartReports presents further opportunities to drive
care improvement by:
• Development of appropriate measures to evaluate outcomes
• Delivering clinical care alerts
Predictive analytics? Patients like me reports?
Decision Support? Giving access to patients and
families? Other?
Summary
Our model can be adopted by other disease foundations or
healthcare organizations that have disease-specific registries.
